An interventional study of High Intensity Aerobic Exercise in Primary Dysmenorrhea, sponsored by Lincoln University College. Completed at 1 site in Malaysia. Open to female participants aged 17 Years to 49 Years. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Lincoln University College · Not applicable, Interventional, and Treatment
Primary dysmenorrhea is common among females of reproductive age and is characterized by painful menstrual cramps without an underlying pelvic disease. This pain can affect daily activities, academic performance, work, and quality of life.
This study aims to investigate the effect of high-intensity aerobic exercise on pain threshold and blood pressure in females with primary dysmenorrhea. The study will assess changes in pain threshold and blood pressure following high-intensity aerobic exercise. The findings may help determine whether this type of exercise can improve pain tolerance and influence blood pressure in females experiencing painful menstrual periods.
Participants will perform a high-intensity aerobic exercise program, and their pain threshold level will be assessed by a digital algometer before and after the exercise intervention and the blood pressure changes will also be studied.
Primary dysmenorrhea is a common gynecological condition characterized by recurrent, cramping pain in the lower abdomen during menstruation in the absence of identifiable pelvic pathology. It is associated with increased production of prostaglandins, which leads to excessive uterine contractions, reduced uterine blood flow, and menstrual pain. Primary dysmenorrhea may negatively affect daily activities, academic performance, work productivity, sleep, and overall quality of life.
Exercise has been suggested as a non-pharmacological approach for managing menstrual pain. Aerobic exercise may influence pain perception through the activation of endogenous pain-inhibitory mechanisms, including the release of endogenous opioids and other pain-modulating substances. Exercise may also improve cardiovascular function and autonomic regulation, potentially influencing blood pressure. However, the effects of high-intensity aerobic exercise on pain threshold and blood pressure in females with primary dysmenorrhea require further investigation.
The purpose of this study is to investigate the effect of high-intensity aerobic exercise on pain threshold and blood pressure in females diagnosed with primary dysmenorrhea. The study will evaluate changes in pain threshold and blood pressure following a structured high-intensity aerobic exercise intervention. The exercise protocol followed is at 85% of heart rate given three times a week for 25 minutes /session. This is according to the American heart association guideline for high intensity Aerobic Exercises
Eligible participants will be females of reproductive age with a history of primary dysmenorrhea who meet the predefined inclusion and exclusion criteria. Participants will undergo baseline assessment, including demographic and relevant clinical information, pain threshold measurement, and blood pressure measurement using standardized procedures.
The intervention group will participate in a structured high-intensity aerobic exercise programme according to the study protocol. Maximum heart rate is calculated for each participant using the Karvonen's Formula and then maximum heart rate is calculated for each participant accordingly. The participants are advised to wear comfortable clothing and also wear smart watch. The exercise programme will specify the type of aerobic activity, exercise intensity, duration of each session, frequency of sessions, total intervention period, and warm-up and cool-down procedures. Exercise intensity will be monitored using an appropriate method, such as heart-rate monitoring or the rating of perceived exertion. Rate of perceived exertion scale was used to to guage the exercise effect after the session and was recorded. Participants will be supervised or monitored as specified in the protocol to promote adherence and safety. The exercises consist of jumping jacks, step climber, mountain climber, knee hugs, lunges, partial squats and others. This exercises were selected and validated by five experts from the field of physiotherapy and exercise.
Pain threshold will be assessed using a standardized and reproducible measurement method, such as a pressure pain threshold assessment with an appropriate algometer, if applicable to the study protocol. Blood pressure will be measured using a validated blood pressure monitor under standardized resting conditions. Systolic and diastolic blood pressure will be recorded at the specified assessment time points. Baseline and post-intervention measurements will be compared to determine changes associated with the exercise programme.
The primary outcome will be the change in pain threshold from baseline to post-intervention. The secondary outcome will be the change in systolic and diastolic blood pressure over the same period. Additional outcomes, if included in the study protocol, may include menstrual pain intensity, exercise adherence, and intervention-related adverse events.
The findings of this study may contribute to a better understanding of the effects of high-intensity aerobic exercise on pain sensitivity and cardiovascular responses in females with primary dysmenorrhea. The results may help inform the development of evidence-based exercise recommendations as a potential non-pharmacological approach to managing primary dysmenorrhea.
430 studies on the registry are indexed under Dysmenorrhea; 107 are open to participants now.
This study's enrollment of 110 is above the median of 62 across 363 interventional studies indexed under Dysmenorrhea.
Browse Dysmenorrhea studies →Lincoln University College is the lead sponsor of 15 studies on the registry; 5 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
High Intensity Aerobic Exercise given at 85 % of heart rate. 3 times/week /25 minute per session with 5 minutes warm up and 5 minutes cool down.
Other: High Intensity Aerobic Exercise
No treatment given.Participants instructed to carry on with usual lifestyle and do not begin any new exercise program
intervention intensity is high and consist of structured exercise program
Pain Threshold
Pain Threshold: Measured using a digital algometer at four muscle sites: trapezius (5 cm from the acromion), biceps (15 cm from the glenoid cavity or 9 cm above the elbow crease), rectus abdominis (4 cm lateral to the umbilicus), and gastrocnemius (midpoint between the popliteal fossa and heel). The 1 cm² probe is pressed vertically at 30 kPa until pain is reported; the device automatically records the threshold in kilograms.
Time frame: Pretest (menstrual days 1-4), post-test 1 (week 4), and post-test 2 (week 8), during menstrual days 1-4.
Blood Pressure
It is measured using Omron Digital blood pressure monitor. Both Systolic and Diastolic blood pressure will be measured.
Time frame: On Pretest- all days of menses (day1-day4) .For Post test 1 (at end of 4th week) , Post test 2(at end of 8th week) during day1-day 4 of menses. Recorded in the left arm three times and average is noted. Measured for experimental and control group.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — pain scores, blood pressure levels
Supporting information: Study protocol, Informed consent form
Time frame: 5th September 2024- 4th Feb 2026
Access criteria: Principal investigator,supervisor, co- supervisor, statistician and if needed publishing study
Data sharing details ↗ · www.utar.edu.my
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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